Medicinal oxygen gas Oxigen Salud 99.5 % v/v 200 bar compressed medicinal gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxígeno Medicinal Gas Oxigen Salud 99.5% v/v 200 bar medicinal compressed gas

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. If you consider any of the adverse effects you experience to be serious, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Oxígeno Medicinal Gas Oxigen Salud is and what it is used for
2. What you need to know before using Oxígeno Medicinal Gas Oxigen Salud
3. How to use Oxígeno Medicinal Gas Oxigen Salud
4. Possible adverse effects
5. How to store Oxígeno Medicinal Gas Oxigen Salud
6. Contents of the pack and other information

1. What Oxígeno Medicinal Gas Oxigen Salud Is and What It Is Used For

Oxygen is an essential element for the body. Oxygen therapy is indicated in the following cases:

• Correction of oxygen deficiency of various origins requiring the administration of oxygen at normal or increased pressure.
• Supplying anaesthesia and resuscitation respirators.
• Administration via nebulizer of medications for inhalation.

2. What you need to know before starting to use Medicinal Oxygen Gas Oxigen Salud

Do not use Medicinal Oxygen Gas Oxigen Salud:

With flammable materials.

Oxygen supports and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the pressure conditions under which the gas is used. However, the most significant fire risks in the presence of oxygen involve combustible compounds, particularly those of a greasy nature (lubricants, oils), and organic materials (plastics, wood, paper, fabrics), which may ignite upon contact with oxygen, either spontaneously or due to a spark, flame, ignition point, or as a result of adiabatic compression.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Medicinal Oxygen Gas Oxigen Salud:

• In certain severe cases of oxygen deficiency. After 6 hours of exposure to 100% oxygen concentration, or after 24 hours of exposure to oxygen concentrations above 70%, pulmonary or neurological toxicity may occur.
• High oxygen concentrations should be used for the shortest possible time and monitored by arterial blood gas analysis, while simultaneously measuring the inhaled oxygen concentration. It is advisable to always use the lowest dose capable of maintaining the arterial partial pressure of oxygen (PaO₂) at 50–60 mmHg (i.e., 5.65–7.96 kPa). After 24 hours of exposure, it is recommended, whenever possible, to maintain an oxygen concentration below 45%.

Precautions for use

• In infants requiring oxygen concentrations above 30%, the arterial partial pressure of oxygen (PaO₂) should be regularly monitored to ensure it does not exceed 100 mmHg (i.e., 13.3 kPa) due to the risk of retinal abnormalities.
• Hyperbaric oxygen therapy: to avoid risks of injury caused by high pressure in body cavities containing air that communicate with the exterior, compression and decompression must be performed slowly.

Use of Medicinal Oxygen Gas Oxigen Salud with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Oxygen toxicity may be increased by: corticosteroids, certain anticancer drugs, paraquat, sympathomimetics, X-rays, or in cases of hyperthyroidism or deficiency of vitamins C and E or glutathione deficiency.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

It has been widely used without any notable adverse effects.

Driving and use of machines

There are no data regarding the effects of Medicinal Oxygen Gas Oxigen Salud on driving and the use of machinery.

3. How to use Oxígeno Medicinal Gas Oxigen Salud

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the correct dose of Oxígeno Medicinal Gas Oxigen Salud and will administer it through a system suitable for your needs, ensuring the delivery of the appropriate amount of oxygen.

If you feel that the effect of Oxígeno Medicinal Gas Oxigen Salud is too strong or too weak, inform your doctor.

If you use more Oxígeno Medicinal than you should

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount inhaled.

In case of overdose, the concentration of inhaled oxygen should be reduced and symptomatic treatment is recommended.

If you interrupt treatment with Oxígeno Medicinal Gas Oxigen Salud

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Medicinal Oxygen Gas Oxigen Salud may produce adverse effects, although not everyone experiences them.

In particular, in chronic respiratory failure, there may be a possibility of apnea onset.

Inhalation of high concentrations of oxygen may cause minor lung collapses.

Administration of oxygen at high pressures may cause injuries to the inner ear (potentially involving a risk of tympanic membrane rupture), sinuses, and lungs (potentially involving a risk of pneumothorax).

Seizure episodes have been reported after administration of 100% oxygen concentration for more than 6 hours, particularly under high-pressure conditions.

Pulmonary injuries may occur following administration of oxygen concentrations exceeding 80%.

In newborns, especially if premature, exposure to high oxygen concentrations (FiO2 > 40%; PaO2 greater than 80 mmHg (i.e., 10.64 kPa)) or prolonged exposure (more than 10 days at FiO2 > 30%) carries a risk of retinopathy, which may appear between 3 and 6 weeks after treatment. This may regress spontaneously, but may also lead to retinal detachment or even permanent blindness.

Patients undergoing high-pressure oxygen therapy in chambers may experience claustrophobia episodes.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medicinal Oxygen Gas Oxigen Salud

Keep this medicine out of the sight and reach of children.

Do not use Medicinal Oxygen Gas Oxigen Salud after the expiry date stated on the container.

All regulations concerning the handling of pressurized containers and the instructions for your specific equipment must be followed.

The following points must be observed regarding storage and transport:

Storage of cylinders:

Cylinders must be stored in a well-ventilated or ventilated area, protected from weather conditions, clean, free from flammable materials, reserved for the storage of medical gases, and capable of being locked.

Empty and full cylinders must be stored separately.

Cylinders must be protected from impact or falling, as well as from sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions. Cylinders with a capacity greater than 5 l must be kept in an upright position with valves closed.

Storage of cylinders at user facilities and in domestic settings:

The cylinder must be installed in a location that protects it from risks of impact or falling (such as a stand with securing chains), sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.

Excessive storage must be avoided.

Transport of cylinders:

Cylinders must be transported using appropriate equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from impact or falling. Special attention must also be paid to securing the regulator to prevent risks of accidental breakage.

During transport in vehicles, cylinders must be securely grouped. Continuous ventilation of the vehicle is mandatory, and smoking must be strictly prohibited.

6. Contents of the pack and other information

Composition of Oxígeno Medicinal Gas Oxigen Salud

• The active substance is Oxygen 99.5% v/v

Appearance of the product and contents of the pack

Oxígeno Medicinal Gas Oxigen Salud is an inhalation gas packaged in cylinders at a pressure of 200 bar at 15°C. The cylinders may be made of steel, compact steel, aluminum, or compact aluminum, with the following volumes:

Cylinders of 0.75 L providing 0.15 m³ at 15°C and a pressure of 1 bar.

Cylinders of 1 L; providing 0.2 m³ at 15°C and a pressure of 1 bar.

Cylinders of 1.4 L; providing 0.28 m³ at 15°C and a pressure of 1 bar.

Cylinders of 1.6 L; providing 0.32 m³ at 15°C and a pressure of 1 bar.

Cylinders of 2 L; providing 0.4 m³ at 15°C and a pressure of 1 bar.

Cylinders of 2.5 L; providing 0.5 m³ at 15°C and a pressure of 1 bar.

Cylinders of 2.75 L; providing 0.55 m³ at 15°C and a pressure of 1 bar.

Cylinders of 3 L; providing 0.6 m³ at 15°C and a pressure of 1 bar.

Cylinders of 3.5 L; providing 0.7 m³ at 15°C and a pressure of 1 bar.

Cylinders of 4 L; providing 0.8 m³ at 15°C and a pressure of 1 bar.

Cylinders of 4.55 L; providing 0.91 m³ at 15°C and a pressure of 1 bar.

Cylinders of 4.7 L; providing 0.94 m³ at 15°C and a pressure of 1 bar.

Cylinders of 5 L; providing 1 m³ at 15°C and a pressure of 1 bar.

Cylinders of 6.7 L; providing 1.34 m³ at 15°C and a pressure of 1 bar.

Cylinders of 7 L; providing 1.4 m³ at 15°C and a pressure of 1 bar.

Cylinders of 10 L; providing 2 m³ at 15°C and a pressure of 1 bar.

Cylinders of 10.7 L; providing 2.14 m³ at 15°C and a pressure of 1 bar.

Cylinders of 13 L; providing 2.6 m³ at 15°C and a pressure of 1 bar.

Cylinders of 13.4 L; providing 2.68 m³ at 15°C and a pressure of 1 bar.

Cylinders of 15 L; providing 3 m³ at 15°C and a pressure of 1 bar.

Cylinders of 20 L; providing 4 m³ at 15°C and a pressure of 1 bar.

Cylinders of 28 L; providing 5.54 m³ at 15°C and a pressure of 1 bar.

Cylinders of 30 L; providing 6 m³ at 15°C and a pressure of 1 bar.

Cylinders of 40 L; providing 8 m³ at 15°C and a pressure of 1 bar.

Cylinders of 50 L; providing 10 m³ at 15°C and a pressure of 1 bar.

Blocks 12x50 600 L; providing 120 m³ at 15°C and a pressure of 1 bar.

Blocks 16x50 800 L; providing 160 m³ at 15°C and a pressure of 1 bar.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

OXIGEN SALUD, S.A.

Carretera Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona)

Manufacturer

OXIGEN SALUD, S.A.

Carretera Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona)

OR

OXIGEN SALUD, S.A.

Polígono Industrial, Calle A, Parcela 63.

09320 Madrigal del Monte (Burgos)

Date of latest review of the package leaflet:

November 2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended exclusively for healthcare professionals

Instructions for use/handling

Do not smoke.

Do not bring near a flame.

Do not grease.

In particular:

• Never introduce this gas into a device suspected of containing combustible materials, especially if they are of a greasy nature;

• Never clean devices containing this gas, or taps, seals, gaskets, closure devices, and valves with combustible products, especially if they are of a greasy nature;

• Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face;

• Do not use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

Medical oxygen cylinders are reserved exclusively for therapeutic use.

To avoid any incidents, the following instructions must be strictly observed:

1. Check the equipment is in good condition before use.

2. Secure cylinders with a capacity greater than 5 L using an appropriate method (chains, hooks, etc.) to keep them in an upright position and prevent accidental falls; do not use cylinders if their pressure is below 10 bar.

3. Never force a cylinder into a support that is too narrow for it.

4. Handle equipment with clean hands, free from grease.

5. Handle cylinders of 50 L or more with clean handling gloves and safety shoes.

6. At the time of delivery by the manufacturer, verify that the cylinder is equipped with an intact tamper-evident seal.

7. Do not handle a cylinder whose tap is not protected by a cap, except for cylinders with a capacity below 5 L.

8. Never lift the cylinder by the tap.

9. Use connections or flexible connection components specifically designed for oxygen.

10. Use a pressure-reducing valve with a flowmeter capable of withstanding a pressure of at least 1.5 times the maximum service pressure (200 bar) of the cylinder (unless a reducer is already integrated into the tap).

11. For cylinder banks, use only pressure gauges calibrated to at least 315 bar.

12. Use flexible connection components on wall outlets, fitted with nozzles specifically designed for oxygen.

13. Open the tap or valve gradually.

14. Never force the tap to open it, nor open it fully.

15. Purge the cylinder's outlet connection before attaching the pressure reducer to remove any dust that may be present. Keep the connections between the cylinder and the pressure reducer clean.

16. Never subject the pressure reducer to repeated pressurizations.

17. Never stand directly in front of the tap outlet; always stand on the side opposite the pressure reducer, behind the cylinder and away from it. Never expose patients to the gas flow.

18. Do not use intermediate connectors to connect two devices that are not compatible with each other.

19. Do not attempt to repair a defective tap.

20. Never tighten the pressure reducer-flowmeter with pliers, as this may damage the seal.

21. Check in advance the compatibility of materials in contact with oxygen, particularly by using oxygen-specific seals for the pressure reducer connections.

22. After use, close the cylinder tap, allow the pressure in the pressure reducer to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated pressure reducers) the pressure regulator adjustment screw.

23. In case of leakage, close the tap or valve supplying the circuit with a leak. Never use a cylinder showing a leak, and check that the emergency device is activated.

24. Never completely empty a cylinder.

25. Store empty cylinders with the tap closed and empty banks with the valve closed (to prevent corrosion in the presence of moisture).

26. Do not transfer pressurized gas from one cylinder to another.

27. Ventilate the area of use if possible, especially in confined spaces (vehicles, homes).